ID

31510

Description

Ezetimibe and Statins on Postprandial Lipemia in Type 2 Diabetes; ODM derived from: https://clinicaltrials.gov/show/NCT00699023

Link

https://clinicaltrials.gov/show/NCT00699023

Keywords

Versions (1)
  1. 8/30/18 8/30/18 -
Copyright Holder

See clinicaltrials.gov

Uploaded on

August 30, 2018

DOI

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License

Creative Commons BY 4.0
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Eligibility Postprandial Lipemia NCT00699023

English

Eligibility Postprandial Lipemia NCT00699023

1 forms  
Inclusion Criteria
Description

Inclusion Criteria

Alias
UMLS CUI
C1512693
type 2 diabetes since at least two years
Description

Non-Insulin-Dependent Diabetes Mellitus Disease length

Data type

boolean

Alias
UMLS CUI [1,1]
C0011860
UMLS CUI [1,2]
C0872146
stable metabolic control (hba1c<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.
Description

Metabolic Control Stable | Hemoglobin A1c measurement | Diet therapy | Oral hypoglycemic | Other Coding | Metformin

Data type

boolean

Alias
UMLS CUI [1,1]
C1513158
UMLS CUI [1,2]
C0205360
UMLS CUI [2]
C0474680
UMLS CUI [3]
C0012159
UMLS CUI [4]
C0359086
UMLS CUI [5]
C3846158
UMLS CUI [6]
C0025598
bmi<30 kg/m2 and body weight stable during the last six months.
Description

Body mass index | Stable body weight

Data type

boolean

Alias
UMLS CUI [1]
C1305855
UMLS CUI [2]
C0517386
both sexes; only post-menopausal women.
Description

Gender | Postmenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0079399
UMLS CUI [2]
C0232970
ldl-cholesterol >130 mg/dl, plasma triglycerides <400 mg/dl.
Description

Serum LDL cholesterol measurement | Plasma triglyceride measurement

Data type

boolean

Alias
UMLS CUI [1]
C0428474
UMLS CUI [2]
C0583329
no use of hypolipidemic drugs in the last three months.
Description

Hypolipidemic Agents Absent

Data type

boolean

Alias
UMLS CUI [1,1]
C0086440
UMLS CUI [1,2]
C0332197
Exclusion Criteria
Description

Exclusion Criteria

Alias
UMLS CUI
C0680251
patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.
Description

Renal Insufficiency | Creatinine measurement, serum | Hepatic impairment | Elevated serum transaminase levels

Data type

boolean

Alias
UMLS CUI [1]
C1565489
UMLS CUI [2]
C0201976
UMLS CUI [3]
C0948807
UMLS CUI [4]
C3808571
patients with history of cardiovascular disease.
Description

Cardiovascular Disease

Data type

boolean

Alias
UMLS CUI [1]
C0007222
pre-menopausal women.
Description

Premenopausal state

Data type

boolean

Alias
UMLS CUI [1]
C0232969
any other acute or chronic degenerative disease.
Description

Degenerative disorder | Degenerative disorder chronic

Data type

boolean

Alias
UMLS CUI [1]
C1285162
UMLS CUI [2,1]
C1285162
UMLS CUI [2,2]
C0205191
anemia (hb<12 g/dl).
Description

Anemia | Hemoglobin measurement

Data type

boolean

Alias
UMLS CUI [1]
C0002871
UMLS CUI [2]
C0518015
uncontrolled blood pressure.
Description

Blood Pressure Uncontrolled

Data type

boolean

Alias
UMLS CUI [1,1]
C0005823
UMLS CUI [1,2]
C0205318
use of any drugs able to interfere with the study medications
Description

Pharmaceutical Preparations Interfere with Investigational New Drugs

Data type

boolean

Alias
UMLS CUI [1,1]
C0013227
UMLS CUI [1,2]
C0521102
UMLS CUI [1,3]
C0013230
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Similar models

Eligibility Postprandial Lipemia NCT00699023

1 forms
Name
Type
Description | Question | Decode (Coded Value)
Data type
Alias
Item Group
C1512693 (UMLS CUI)
Non-Insulin-Dependent Diabetes Mellitus Disease length
Item
type 2 diabetes since at least two years
boolean
C0011860 (UMLS CUI [1,1])
C0872146 (UMLS CUI [1,2])
Metabolic Control Stable | Hemoglobin A1c measurement | Diet therapy | Oral hypoglycemic | Other Coding | Metformin
Item
stable metabolic control (hba1c<8.0%) for at least six months on diet or diet+oral hypoglycemic drugs (insulin secretagogues or metformin), not to be changed during the study period.
boolean
C1513158 (UMLS CUI [1,1])
C0205360 (UMLS CUI [1,2])
C0474680 (UMLS CUI [2])
C0012159 (UMLS CUI [3])
C0359086 (UMLS CUI [4])
C3846158 (UMLS CUI [5])
C0025598 (UMLS CUI [6])
Body mass index | Stable body weight
Item
bmi<30 kg/m2 and body weight stable during the last six months.
boolean
C1305855 (UMLS CUI [1])
C0517386 (UMLS CUI [2])
Gender | Postmenopausal state
Item
both sexes; only post-menopausal women.
boolean
C0079399 (UMLS CUI [1])
C0232970 (UMLS CUI [2])
Serum LDL cholesterol measurement | Plasma triglyceride measurement
Item
ldl-cholesterol >130 mg/dl, plasma triglycerides <400 mg/dl.
boolean
C0428474 (UMLS CUI [1])
C0583329 (UMLS CUI [2])
Hypolipidemic Agents Absent
Item
no use of hypolipidemic drugs in the last three months.
boolean
C0086440 (UMLS CUI [1,1])
C0332197 (UMLS CUI [1,2])
Item Group
C0680251 (UMLS CUI)
Renal Insufficiency | Creatinine measurement, serum | Hepatic impairment | Elevated serum transaminase levels
Item
patient with renal (serum creatinine >1.5 mg/dl) or hepatic (serum transaminases >three times upper normal values) impairment.
boolean
C1565489 (UMLS CUI [1])
C0201976 (UMLS CUI [2])
C0948807 (UMLS CUI [3])
C3808571 (UMLS CUI [4])
Cardiovascular Disease
Item
patients with history of cardiovascular disease.
boolean
C0007222 (UMLS CUI [1])
Premenopausal state
Item
pre-menopausal women.
boolean
C0232969 (UMLS CUI [1])
Degenerative disorder | Degenerative disorder chronic
Item
any other acute or chronic degenerative disease.
boolean
C1285162 (UMLS CUI [1])
C1285162 (UMLS CUI [2,1])
C0205191 (UMLS CUI [2,2])
Anemia | Hemoglobin measurement
Item
anemia (hb<12 g/dl).
boolean
C0002871 (UMLS CUI [1])
C0518015 (UMLS CUI [2])
Blood Pressure Uncontrolled
Item
uncontrolled blood pressure.
boolean
C0005823 (UMLS CUI [1,1])
C0205318 (UMLS CUI [1,2])
Pharmaceutical Preparations Interfere with Investigational New Drugs
Item
use of any drugs able to interfere with the study medications
boolean
C0013227 (UMLS CUI [1,1])
C0521102 (UMLS CUI [1,2])
C0013230 (UMLS CUI [1,3])
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